Provides for a decrease in dose of 13C-urea from 125 mg to 75 mg in the BreathTekTM UBT Collection Kit.

ALENDRONATE SODIUM

MERCK

20-560

31-Mar-00

31-Jan-01

SE2

025

N

10.1

Provides for the consideration of using Fosamax 70 mg in men once weekly for the treatment to increase bone mass in men with osteoporosis.

AMPRENAVIR

GLAXO WELLCOME

21-007

14-Jul-00

11-May-01

SE7

006

N

9.9

Provides for the use of Agenerase in combination with other antiretroviral agents for the treatment of HIV-1 infection.

AMPRENAVIR

GLAXO WELLCOME

21-039

14-Jul-00

11-May-01

SE7

006

N

9.9

Provides for the use of Agenerase in combination with other antiretroviral agents for the treatment of HIV-1 infection.

AZITHROMYCIN

PFIZER

50-710

16-Feb-01

14-Dec-01

SE2

008

N

9.9

Provides for the use of Zithromax (azithromycin) for Oral Suspension for acute otitis media with a 1-day dosing regimen.

AZITHROMYCIN

PFIZER

50-710

16-Feb-01

14-Dec-01

SE2

009

N

9.9

Provides for the use of Zithromax (azithromycin) for Oral Suspension for acute otitis media with a 3-day dosing regimen.

BETAMETHASONE DIPROPIONATE

SCHERING

17-536

5-Oct-00

3-Oct-01

SE5

024

X

11.9

Provides for labeling revisions. Specifically, S-024 provides for labeling revisions based on the results of pediatric safety studies conducted with DIPROSONE (betamethasone dipropionate) Cream, 0.05%, in patients with atopic dermatitis, 12 years of age and younger, and supersedes S-018.

BETAMETHASONE DIPROPIONATE

SCHERING

17-691

5-Oct-00

3-Oct-01

SE5

024

X

11.9

Provides for labeling revisions. Specifically, S-024 provides for labeling revisions based on the results of pediatric safety studies conducted with DIPROSONE (betamethasone dipropionate) Ointment, 0.05%, in patients with atopic dermatitis, 12 years of age and younger, and supersedes S-019.

BETAMETHASONE DIPROPIONATE

SCHERING

17-781

5-Oct-00

3-Oct-01

SE5

022

X

11.9

Provides for labeling revisions. Specifically, S-022 provides for labeling revisions based on the results of pediatric safety studies conducted with DIPROSONE (betamethasone dipropionate) Lotion, 0.05%, in patients with atopic dermatitis, 12 years of age and younger, and supersedes S-015.

BETAMETHASONE DIPROPIONATE

SCHERING

19-555

5-Oct-00

3-Oct-01

SE5

016

X

11.9

Provides for labeling revisions. Specifically, S-016 provides for labeling revisions based on the results of pediatric safety studies conducted with DIPROLENE AF Cream in patients with atopic dermatitis, 12 years of age and younger, and supersedes S-008.

BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION

ALLERGAN

20-490

15-Aug-01

20-Dec-01

SE5

007

N

4.2

Proposes a change in the wording of the pediatric section of the package inserts.

BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION

ALLERGAN

20-613

15-Aug-01

20-Dec-01

SE5

018

N

4.2

Proposes a change in the wording of the pediatric section of the package inserts.

BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION

ALLERGAN

21-262

15-Aug-01

20-Dec-01

SE5

006

N

4.2

Proposes a change in the wording of the pediatric section of the package inserts.

BUSPIRONE HCL

BRISTOL MYERS SQUIBB

18-731

21-Mar-00

19-Jul-01

SE5

043

N

15.9

Provides for new language for pediatric use.

BUTENAFINE HCL

BERTEK PHARMS

20-524

7-Aug-00

6-Jun-01

SE1

005

N

10.0

Provides for the use of Mentax (butenafine HCl cream) Cream, 1%, for the topical treatment of tinea (pityriasis) versicolor due to Malassezia furfur (formerly Pityrosporum orbiculare).

BUTENAFINE HYDROCHLORIDE

SCHERING PLOUGH

21-307

29-Sep-00

7-Dec-01

N

000

N

14.3

Provides for the use without prescription of Lotrimin Ultra butenafine hydrochloride cream 1%, for the topical treatment of the following superficial dermatophytoses: interdigital tinea pedis (athlete's foot), tinea corporis (ringworm) and tinea cruris (jock itch) due to E. floccosum, T. mentagrophytes, T. rubrum, and T. tonsurans.

CAPCITABINE

HLR

20-896

8-Mar-01

7-Sep-01

SE7

010

Y

6.0

Provides for the use of Xeloda (capcitabine) Tablets in combination with Taxotere (docetaxel) for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior anthracycline containing chemotherapy.

CAPECITABINE

HLR

20-896

20-Sep-99

30-Apr-01

SE1

006

N

19.3

Provides for the use of XELOD as first-line treatment of patients with metastatic colorectal carcinoma when treatment with fluoropyrimidine therapy alone is preferred.

CARVEDILOL

GLAXO SMITH KLINE

20-297

2-Mar-01

1-Nov-01

SE1

007

N

8.0

Provides for the use of Coreg (carvedilol) 3.125, 6.25, 12.5 and 25 mg Tablets for severe heart failure.

CELECOXIB CAPSULE

SEARLE

20-998

19-Dec-00

18-Oct-01

SE1

010

N

10.0

Provides for the use of Celebrex (celecoxib capsule) Capsules 100 mg, and 200 mg for the management of acute pain in adults and the treatment of primary dysmenorrhea.

Provides final pediatric study reports and a safety update in response to the Pediatric Written Request and supersedes S-007, S-009, and S-020.

CROMOLYN SODIUM NASAL SOLUTION

PHARMACIA UPJOHN

20-463

31-Aug-99

27-Mar-01

SE5

002

N

18.9

Provides for the use of NasalCrom Nasal Solution (cromolyn sodium nasal solution) nasal spray for use in children down to 2 years of age.

DELAVIRDINE MESYLATE

AGOURON

20-705

17-Jul-00

16-May-01

SE7

008

N

10.0

Provides for the use of RESCRIPTOR for the treatment of HIV-1 infection in combination with at least 2 other active antiretroviral agents when therapy is warranted.

DOPAMINE HCL AND 5% DEXTROSE INJECTION IN PLASTIC CONTAINER

BAXTER HLTHCARE

19-615

24-Jun-99

17-Apr-01

SE5

012

N

21.8

Provides for final printed labeling revised as follows: Changes in the PRECAUTIONS, Pediatric Use subsection and the addition of a new Pediatric Dosing and Administration subsection under DOSAGE and ADMINISTRATION.

EPTIFIBATIDE

COR

20-718

30-Jun-00

8-Jun-01

SE2

010

N

11.3

Provides for labeling revised to reflect the findings of the ESPRIT ("Enhanced Suppression of the Platelet IIb/IIIa Receptor with Integrilin Therapy (the 'ESPRIT Study); A Phase III Study in Patients Undergoing Percutaneous Coronary Intervention with Stent Implantation") study. The revisions include a new dosing recommendation for patients undergoing Percutaneous Coronary Intervention (PCI) and a revised recommended target range for the activated clotting time (ACT) during PCI.

ESOMEPRAZOLE MAGNESIUM

ASTRAZENECA

21-154

28-Feb-00

20-Feb-01

N

000

N

11.8

Provides for the use of Nexium (esomeprazole magnesium) Delayed-Release Capsules in combination with clarithromycin and amoxicillin for the eradication of Helicobacter pylori in patients with duodenal ulcer disease or a history of duodenal ulcer disease.

ESTRADIOL TRANSDERMAL SYSTEM

BERLEX LABS

20-375

5-Jun-00

5-Apr-01

SE1

016

N

10.0

Provides for the use of the 0.025 mg/day Climara (Estradiol transdermal System) for the treatment of moderate to severe vasomotor symptoms and vulvar and vaginal atrophy associated with the menopause.

FLUOCINOLONE ACETONIDE

HILL DERM

19-452

10-Oct-00

10-Oct-01

SE5

017

N

12.0

Provides for the use of Derma-Smoothe/FS in pediatric patients 2 years and older for the treatment of atopic dermatitis.

GATIFLOXACIN

BRISTOL MYERS SQUIBB

21-061

21-Dec-00

12-Oct-01

SE2

007

N

9.7

Provides for a change in the dosing regimen for the treatment of acute exacerbation of chronic bronchitis (AECB) to five (5) days duration.

GATIFLOXACIN

BRISTOL MYERS SQUIBB

21-062

3-Jan-01

12-Oct-01

SE2

008

N

9.3

Provides for a change in the dosing regimen for the treatment of acute exacerbation of chronic bronchitis (AECB) to five (5) days duration.

INSULIN ASPART [rDNA ORIGIN] INJECTION

NOVO NORDISK PHARM

20-986

21-Dec-00

21-Dec-01

SE3

003

N

12.0

Provides for the use of NovoLog with the following external insulin pumps: 1. Disertronic H-TRON plus V100 with Disertronic 3.15 plastic cartridges and Classic or Tender infusion sets, or 2. MiniMed Models 505, 506, or 507 with Minimed 3 mL syringes and Polyfin or Sof-set infusion sets.

IRBESARTAN

SANOFI SYNTHELABO

20-757

17-Feb-00

26-May-01

SE5

014

N

15.3

Provides for final printed labeling revised as follows: Under CLINICAL PHARMACOLOGY, the Special Populations, the Pediatric subsection has been changed. Under PRECAUTIONS, Pediatric Use, a second paragraph has been added. Under DOSAGE and ADMINISTRATION, a Pediatric Patients subsection has been added. Under HOW SUPPLIED, the 75 mg Blister Pack of 100 (NDC# 0087-2771-35) has been removed.

ITRACONAZOLE

JANSSEN

20-657

1-May-00

9-May-01

SE1

005

N

12.3

Provides for the use of Sporanox Injection for empiric therapy in febrile neutropenic patients with suspected fungal infections (ETFN).

ITRACONAZOLE

JANSSEN

20-966

1-May-00

9-May-01

SE1

004

N

12.3

Provides for the use of Sporanox Injection for empiric therapy in febrile neutropenic patients with suspected fungal infections (ETFN).

LAMIVUDINE

GLAXO WELLCOME

21-003

28-Feb-01

16-Aug-01

SE1

002

N

5.6

Provides for the use of Epivir-HBV in the treatment of hepatitis B in pediatric patients ages 2-17 years.

LAMIVUDINE

GLAXO WELLCOME

21-004

28-Feb-01

16-Aug-01

SE1

002

N

5.6

Provides for the use of Epivir-HBV in the treatment of hepatitis B in pediatric patients ages 2-17 years.

LETROZOLE

NOVARTIS PHARMS

20-726

12-Jul-00

10-Jan-01

SE1

006

Y

6.0

Provides for the use of Femara for first-line treatment of postmenopausal women with hormone receptor positive or hormone receptor unknown locally advanced or metastatic breast cancer.

LEUPROLIDE ACETATE FOR DEPOT SUSPENSION

TAP PHARM

20-011

22-Nov-00

21-Sep-01

SE1

021

N

10.0

Provides for the use of Lupron Depot 3.75 mg monthly with norethindrone acetate 5 mg daily for initial management of endometriosis and for management of recurrence of symptoms. Duration of initial treatment or retreatment should be limited to 6 months.

LEUPROLIDE ACETATE FOR DEPOT SUSPENSION

TAP PHARM

20-708

22-Nov-00

21-Sep-01

SE1

011

N

10.0

Provides for the use of Lupron Depot-3 Month 11.25 mg with norethindrone acetate 5 mg daily for initial management of endometriosis and for management of recurrence of symptoms. Duration of initial treatment or retreatment should be limited to 6 months.

METOPROLOL SUCCINATE

ASTRAZENECA

19-962

10-Sep-99

5-Feb-01

SE1

013

N

16.9

Provides for the new use of Toprol-XL (metoprolol succinate) Tablets for the treatment of congestive heart failure and for a 25 mg dosage strength scored tablet.

Provides for the use of MONISTAT 1 COMBINATION PACK for the treatment of vulvovaginal candidiasis.

MOXIFLOXACIN HCL

BAYER

21-334

10-Dec-98

27-Apr-01

N

000

N

28.6

Provides for the use of Avelox for the treatment of uncomplicated skin and skin structure infections.

NORETHINDRONE ACETATE, 1MG, AND ETHINYL ESTRADIOL, 35MCG

PARKE DAVIS

21-276

3-Jul-00

1-Jul-01

N

000

N

11.9

Provides for the use of ESTROSTEP 21 and ESTROSTEP Fe Tablets for the treatment of moderate acne vulgaris in females, >15 years of age, who have no known contraindications to oral contraceptive therapy, desire oral contraception, have achieved menarche, and are unresponsive to topical anti-acne medications.

PAMIDRONATE DISODIUM INJECTION

NOVARTIS PHARM

20-036

13-Aug-01

20-Aug-01

SE2

024

N

0.2

Proposes to change the administration rate for the infusion of Aredia from 24 hours to 2 to 24 hours. This change applies to the indication for the treatment of moderate and severe hypercalcemia of malignancy, with or without bone metastases.

PANTOPRAZOLE SODIUM

WYETH AYERST LABS

20-987

12-Jun-00

12-Jun-01

SE1

001

N

12.0

Proposes the use of PROTONIX (pantoprazole sodium) Delayed-Release Tablets for the following new indication: Maintenance of Healing of Erosive Esophagitis and control of daytime and nighttime heartburn symptoms in patients with gastroesophageal reflux disease (GERD).

PANTOPRAZOLE SODIUM

WYETH AYERST LABS

20-988

20-Apr-01

19-Oct-01

SE1

003

Y

6.0

Provides for the use of Protonix I.V. for Injection in the treatment of pathological hypersecretion associated with Zollinger-Ellison Syndrome (ZES).

PAROXETINE HCL

SKB PHARMS

20-031

28-Apr-00

13-Apr-01

SE1

026

N

11.5

Provides for the use of Paxil (paroxetine hydrochloride) Tablets for the treatment of generalized anxiety disorder as a new indication.

PAROXETINE HYDROCHLORIDE

SKB PHARMS

20-031

21-Jul-00

14-Dec-01

SE1

029

N

16.8

Provides for the use of Paxil (paroxetine hydrochloride) Tablets for the treatment of posttraumatic stress disorder as a new indication.

PRAVASTATIN SODIUM

BRISTOL MYERS SQUIBB

19-898

1-Mar-01

18-Dec-01

SE2

046

N

9.6

Provides for the use of a new dosage strength (80 mg) and dosing regimen (80 mg once per day) of Pravachol (pravastatin sodium) tablets.

PROPOFOL

ASTRAZENECA UK

19-627

21-May-99

23-Feb-01

SE5

035

N

21.2

Provides for the use of Diprivan (propofol) Injectable Emulsion in patients 3 months to 16 years old for general anesthesia.

SIBUTRAMINE HCL MONOHYDRATE

KNOLL PHARM

20-632

18-Apr-00

16-Feb-01

SE2

011

N

10.0

Provides for an addition to the CLINICAL STUDIES and the DOSAGE AND ADMINISTRATION sections of the labeling indicating the maintenance of weight loss over an 18 month period thus extending the use of this drug from 1 year to 2 years.

SOMATROPIN [rDNA origin] FOR INJECTION

PHARMACIA AND UPJOHN

20-280

3-Jul-00

25-Jul-01

SE1

031

Y

12.7

Provides for the use of Genotropin (somatropin [rDNA origin] for injection) for long-term treatment of growth failure in children born small for gestational age who fail to manifest catch-up growth by two years of age.

TAZAROTENE

ALLERGAN

21-184

11-Dec-00

11-Oct-01

SE1

001

N

10.0

Provides for the use of Tazorac (tazarotene) Cream, 0.1% for acne vulgaris.

TICLOPIDINE HCL

SYNTEX (USA) LLC

19-979

24-Jan-00

18-Apr-01

SE1

018

N

14.8

Provides for the new use of Ticlid (ticlopidine hydrochloride) Tablets as adjunctive therapy with aspirin to reduce the incidence of subacute stent thrombosis in patients undergoing successful coronary stent implantation.

TOPIRAMATE

JOHNSON RW

20-505

1-Aug-97

28-Aug-01

SE1

002

N

48.9

Provides for the use of Topamax (topiramate) Tablets as adjunctive therapy in patients 2 years and older with seizures associated with Lennox-Gastaut syndrome.

TOPIRAMATE

JOHNSON RW

20-844

8-Jun-01

28-Aug-01

SE1

010

N

2.7

Provides for the use of Topamax (topiramate) Sprinkle Capsule as adjunctive therapy in patients 2 years and older with seizures associated with Lennox-Gastaut syndrome.

TRIMETHOBENZAMIDE HYDROCHLORIDE

KING PHARMS

17-531

14-Feb-01

13-Dec-01

SE2

010

N

9.9

Provides for the following in response to the Federal Register notice of January 9, 1979, classifying this drug effective for postoperative nausea and vomiting and nausea associated with gastroenteritis: draft labeling, results of bioavailability studies, and updated manufacturing and controls and testing procedures.

VALACYCLOVIR HCL

GLAXO WELLCOME

20-550

31-Aug-00

25-Jun-01

SE2

012

N

9.8

Provides for a labeling indication for a shorter treatment course of three days in the treatment of recurrent episodes of genital herpes.

VENLAFAXINE HCL

WYETH AYERST LABS

20-151

19-May-00

2-May-01

SE1

017

N

11.4

Provides for the use of Effexor Tablets for the prevention of recurrence of depression and for the prevention of relapse of depression.

VENLAFAXINE HCL

WYETH AYERST LABS

20-151

22-May-00

2-May-01

SE1

018

N

11.3

Provides for the use of Effexor Tablets for the prevention of recurrence of depression and for the prevention of relapse of depression.

VENLAFAXINE HCL

WYETH AYERST LABS

20-699

5-May-00

2-May-01

SE1

015

N

11.9

Provides for the use of Effexor XR Capsules for the prevention of recurrence of depression and for the prevention of relapse of depression.

VENLAFAXINE HCL

WYETH AYERST LABS

20-699

22-May-00

2-May-01

SE1

016

N

11.3

Provides for the use of Effexor XR Capsules for the prevention of recurrence of depression and for the prevention of relapse of depression.

VERTEPORFIN FOR INJECTION

QLT

21-119

14-Aug-00

22-Aug-01

SE1

001

Y

12.3

Provides for the use of Visudyne (verteporfin for injection) therapy for the treatment of patients with predominantly classic subfoveal choroidal neovascularization due to macular degeneration, presumed ocular histoplasmosis or pathologic myopia.

ZAFIRLUKAST

ASTRAZENECA

20-547

30-Jun-00

27-Apr-01

SE1

014

N

9.9

Provides for the use of Accolate 10mg for the prophylaxis and chronic treatment of asthma in pediatric patients 5 - 6 years of age.

*Supplement Type

Description for SE1 - SE7

N (Chemical Type 6)SE1SE2SE3SE4SE5SE6SE7

NDA Type 6 - New IndicationNew or modified indicationNew dosage regimenNew route of administrationComparative efficacy claimPatient population alteredChange the marketing status from prescription to over the counter useComplete the traditional approval of a product originally approved under subpart H (accelerated approval)